Associate Development Engineer

HISTOSONICS•Plymouth, MN

6d•Hybrid

About The Position

The Associate Development Engineer works with the HistoSonics team to design, engineer, develop, and test globally regulated clinical systems. The role serves as an engineering lead in the design and build of systems or subsystems related to the company’s products and supports product launches. It also contributes to remediating existing design drawings and specifications to meet growing business needs. The engineer develops an understanding of the HistoSonics system, the interactions among its subsystems, and how Edison software interacts with those subsystems. The position supports product-related engineering across mechanical, electrical, software, and system-integration tasks, along with design documentation and transfer-to-manufacturing activities.

Requirements

Bachelor’s degree in Mechanical, Biomedical, or related engineering.
0–2 years of related work experience.
Experience with engineering software such as MATLAB, SolidWorks, or Minitab.
Excellent written and verbal communication skills.
Excellent attention to detail.
Ability to work somewhat independently in a collaborative, fast-paced environment.

Nice To Haves

Related work experience in the medical device industry.
CAD experience; strongly preferred.
Experience working within a Quality Management System.

Responsibilities

Develop an understanding of the HistoSonics system, the interactions between its subsystems, and how Edison software interacts with each subsystem.
Remediate existing design specifications using input from cross-functional teams.
Design, engineer, and develop product-related mechanical systems, subsystems, and devices, including electrical, mechanical, software, and system-integration tasks.
Develop engineering specifications and R&D tests; conduct detailed mechanical design, design reviews, risk analysis, hazard analysis, and FMEA for design, process, and use.
Conduct or support engineering analyses and evaluations, including tolerance, material selection, force, stress, thermal, and ex vivo or preclinical testing.
Support engineering for manufacturability and transfer to manufacturing, including assessment of molds and tools, manufacturing equipment definition and validation, process definition and validation, engineering builds, and product verification testing.
Ensure design documentation complies with the company’s design control system or an external partner’s system, and ensure project deliverables are met.
Support product launch activities.